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The biotech news stories we’re keeping an eye on

STAT

Today, we see insulin-producing cells survive in a human body without triggering an immune rejection, and have some big news from CMS. Hope those of you who were in San Francisco for J.P. Morgan are resting, recovering, and not coping with any quad-emic strains. Read the rest…

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How GLP-1’s moved from research labs to national TV

STAT

Today, we’re reading about the world’s costliest drug, plus we learn about immune senescence and a potential cause for a kidney autoimmune disease. Sign up to get it in your inbox here. It’s Meghana. Read the rest…

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STAT+: Medicare would have saved $3.7 billion on Part B drugs if inflationary rebates were around in a recent three-year period

STAT

More specifically, 70 of the 93 top-selling drugs covered by the Medicare Part B program – which are typically pricier medicines that are administered by physicians or in hospitals – between 2018 and 2020 would have been subject to inflationary rebates each year, according to the analysis published in JAMA.

Immunity 246
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Blackstone wants in on red-hot immunology market

STAT

The need-to-know this morning Biogen  and  Ionis Pharmaceuticals  are  ending their development  of an experimental drug for ALS based on results of a Phase 1/2 trial. Novartis  said it’s  met all tender offer conditions  to acquire German biotech Morphosys.

Immunity 235
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STAT+: Pharmalittle: We’re reading about drug shortages, what drugmakers didn’t tell Alzheimer’s trial patients and more

STAT

Among the basic and life-saving medicines for which shortages continue to be problematic are Rho(D) immune globulin, pain and sedation medications, and ADHD pills. So far this year, 95 new shortages were reported, a drop from 156 in 2023, although 50% of active shortages have persisted for two or more years.

Immunity 243
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September 2023 Newsletter

Safe Biologics

The product is an interleukin-6 (IL-6) receptor antagonist that targets specific inflammatory proteins to suppress the immune system. Pitts: The IRA makes the risks of developing new drugs too high On September 14th, an op-ed by former FDA Associate Commissioner Peter J. It is administered via intravenous infusion.

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Preliminary Injunction Decision in Chambers of Commerce Case Provides First Insights Into Merits of Medicare Negotiations Cases

FDA Law Blog: Biosimilars

By Faraz Siddiqui — Last week, a federal court in Ohio denied a preliminary injunction motion by four Chambers of Commerce in their lawsuit against the Medicare Drug Price Negotiation Program. Judge Newman explained that, under Sixth Circuit precedent, “[e]conomic loss does not constitute irreparable harm, in and of itself.”